This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Although medications are first-line treatment for smoking cessation in adults (1), and 30-40% of obstetricians prescribe or recommend over-the-counter nicotine replacement therapies for smoking cessation during pregnancy (2,3), little information on the efficacy or safety of these products is available for pregnant smokers. We propose a randomized, placebo-controlled, clinical trial to assess the utility of nicotine gum for smoking cessation during pregnancy. Subjects for this trial will be recruited from a large prenatal clinic in Hartford, Connecticut. This clinic serves an indigent population with a smoking rate of 29%. In addition to testing the efficacy and safety of the intervention, we will examine predictors of response among the women and we will conduct an analysis of maternal genetic factors that can augment the adverse effects of smoking on the fetus.
The specific aims of this study are: to compare the efficacy of nicotine gum or a matching placebo for smoking cessation among pregnant smokers. To examine whether nicotine versus placebo gum reduces the number of cigarettes smoked per day by pregnant smoker; to evaluate the safety of nicotine gum for smoking cessation during pregnancy. Specifically, we will compare nicotine gum with placebo on overall nicotine exposure (as measured by salivary cotinine), overall tobacco exposure (as measured by exhaled carbon monoxide and urinary alkaloids), and birth weight at the time of delivery; to identify factors that determine which subjects benefit the most from the use of nicotine replacement therapy for smoking cessation during pregnancy; and to examine the interaction between maternal smoking and allelic variation at two genetic loci (CYP1A1 and GSTT1) on birth weight in a racially diverse sample of pregnant smokers. As an exploratory aim we will also evaluate the interaction between smoking cessation and allele variations of other selected phase I and II genes of drug metabolism on birth weight.
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